,Medical Device Registration in Hong Kong Overview
Begin Your Market Entry Success in Hong Kong with Freyr's Expertise!
Hong Kong's medical device industry is rapidly evolving, establishing itself as a pivotal player in the global healthcare market. The Medical Device Division (MDD), formerly known as the Medical Device Control Office (MDCO), was established in July 2004 to oversee medical device regulations in Hong Kong. With a robust Regulatory framework, registering medical devices in Hong Kong is essential for companies willing to enter this vibrant and competitive landscape.
Discover how Freyr's medical device Regulatory experts can streamline your Hong Kong medical device consulting needs with comprehensive end-to-end services.
The MDD has launched the voluntary Medical Device Administrative Control System (MDACS). Medical devices can be registered voluntarily through the MDACS. The MDACS covers Classes II to IV (medium to high risk) general medical devices, Classes B to D (medium to high risk) In-vitro Diagnostic (IVD) medical devices.
| Authority | The Medical Device Division (MDD) overseen by DOH |
|---|---|
| Regulation | There is no specific legislation that regulates the manufacture, import, export, and sale of medical devices. Manufacturer should refer the guidance notes and the technical reference released by the MDACS for voluntary listing of medical devices and In vitro Diagnostic (IVD) medical devices.
|
| Pathway | Voluntary Listing |
| Authorized Representative (AR) | Local Responsible Person (LRP) |
| Quality Management System (QMS) Requirement | ISO 13485 |
| Validity of License | Five (05) years |
| Labeling Requirements (Language) | English (Technical documents) and Chinese (Labeling and few other documents, wherever applicable) |
| Submission | Online |
Medical Device and IVD Classification in Hong Kong
The Hong Kong Medical Device Division (HKMDD) employs a four (04)-level risk classification system, following the guidelines in TR-003 for medical devices and TR-006 for IVD devices. As with many systems, Regulatory oversight intensifies with higher risk levels. These classification rules are based on the IMDRF classification guidelines.
General Medical Devices
| Class | Risk Level | Examples |
|---|---|---|
| Class I | Low Risk | Surgical retractors/Tongue depressors |
| Class II | Low-Moderate Risk | Hypodermic needles/Suction equipments |
| Class III | Moderate-High Risk | Lung ventilators/Bone fixation plate |
| Class IV | High Risk | Heart valves/Implantable defibrillator |
In-vitro Diagnostic (IVD) Medical Devices
| Class | Risk Level | Examples |
|---|---|---|
| Class A | Low individual risk and/or Low public health risk | Clinical chemistry analyzer/plain urine cup |
| Class B | Moderate individual risk and/or Low public health risk | Vitamin B12/urine test strips |
| Class C | High individual risk and/or Moderate public health risk | Blood glucose self-testing/HLA typing |
| Class D | High individual risk and/or High public health risk | HIV blood diagnostics/Rhesus typing |
Local Responsible Person (LRP)
A Local Responsible Person (LRP) plays a critical role in the medical device registration process in Hong Kong. Acting as the primary Point of Contact (PoC) between the manufacturer and the Medical Device Division (MDD), the LRP ensures that all the Regulatory requirements are met and maintained. This includes overseeing the submission of the necessary documentation, managing compliance with local regulations, and handling any Post-market Surveillance (PMS) activities. The LRP's expertise in local Regulatory practices and their ability to effectively communicate with the MDD are essential for a smooth and successful device registration process.
Medical Device Approval Process In Hong Kong
Freyr Competencies for Hong Kong Market Entry:
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Hong Kong Medical Device Classification![]()
Local Responsible Person (LRP) in Hong Kong![]()
ISO 13485:2016 Compliance![]()
Medical Devices/IVD Registration in Hong Kong![]()
Design Dossier Review, Compilation, and Submission![]()
Medical Device Regulatory Strategy Report![]()
Labeling Compliance Support![]()
Post-market Surveillance (PMS) Support
Frequently Asked Questions (FAQs)
Currently, medical device registration in Hong Kong is voluntary, except for devices that are subject to other ordinances (e.g. those with drug components or emitting radiation). However, hospitals and healthcare providers often prefer to use registered devices, and the government plans to make registration mandatory in the future.
Yes, evidence of approval from reference countries (e.g., US, EU, Japan) can be used to support the Hong Kong registration process.
The MDACS is a voluntary system established by the Department of Health to facilitate the market surveillance and control of medical devices in Hong Kong.
Medical Device Regulatory Consulting – Proven Expertise
Why Freyr?
- Freyr boasts a team of Regulatory experts with extensive experience in navigating the complex Regulatory landscape of Hong Kong and other international markets.
- Freyr offers end-to-end Regulatory services, including device classification, documentation preparation, submission, and Post-market Surveillance (PMS), ensuring a smooth registration process.
- Freyr can act as your LRP, managing all interactions with the Medical Device Division (MDD) and ensuring that your registration process is handled professionally.